Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)

NCT ID: NCT01424787

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-03-31

Brief Summary

The objective of this non-interventional study is to confirm that with standard OsvaRen® treatment it is possible to achieve in at least 60% of the patients the levels of phosphorus, total calcium, and iPTH seen in the CALMAG study also in the normal clinical practice.

Detailed Description

Only a small fraction of haemodialysis patients meet the published NKF-KDOQI standards for calcium, phosphorus, calcium x phosphorus product and intact parathyroid hormone. One of the reasons is the still difficult and insufficient therapy with phosphate binders. Even though calcium containing phosphate binders have been proven to be effective, they are reported to lead in certain patients to hypercalcaemia. This observational study therefore not only evaluates the efficacy of the phosphate binder OsvaRen® (containing calcium acetate and magnesium carbonate) but also the frequency of untoward events in daily practice as well as to the state of hyper-/ hypoparathyroidism as represented by serum iPTH values and the practice patterns used to adjust to and to fully exploit the qualities of the different available phosphate binders. In addition, the compensatory actions of the physicians, such as adaptation of the dialysate calcium or the combination with non-calcium containing phosphate binders, are going to be monitored. In order to receive additional safety data in the context of daily practice, the frequency of untoward events related to the treatment will be documented and analysed.

Conditions

Hyperphosphataemia; ESRD

Study Design

• Observational Model Type: COHORT

Study Groups

OsvaRen treatment

Dialysis patients on OsvaRen treatment

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Signed Informed Consent
• Patient on maintenance haemodialysis, online haemodiafiltration, or peritoneal dialysis at the time of OsvaRen® prescription
• Patients being treated with OsvaRen® for up to 6 months at the day of inclusion

Exclusion Criteria

• Prior participation in this observational study
• Use of OsvaRen® for purposes other than those indicated in the Summary of Product Characteristics (SmPC) / package leaflet

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siro Clinpharm Germany GmbH

INDUSTRY

Sponsor Role: collaborator

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helmut Geiger, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Frankfurt, Germany

Locations

Regionshospitalet Holstebro

Holstebro, Holstebro, Denmark

Nykøbing Falster Sygehus

Nykøbing Mors, Nykobing, Denmark

Roskilde Sygehus

Roskilde, Roskilde, Denmark

Viborg Sygehus

Viborg, Viborg, Denmark

Dialysezentrum

Aachen, , Germany

Dialysezentrum

Alsfeld, , Germany

Dialyszentrum/Gemeinschaftspraxis

Augsburg, , Germany

Nephrologicum Lausitz

Cottbus, , Germany

Studienzentrum Karlstraße

Düsseldorf, , Germany

Dialyse am Lichtbogen

Essen, , Germany

Diakonissenkrankenhaus Flensburg

Flensburg, , Germany

PHV-Dialysezentrum Goslar

Goslar, , Germany

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Hanover, , Germany

Gemeinschaftspraxis Nephrologie/Dialyse

Hoyerswerda, , Germany

Internistische Schwerpunktpraxis Gastroenterologie / Nephrologie

Kaiserslautern, , Germany

PHV Dialysezentrum Kiel

Kiel, , Germany

Gemeinschaftspraxis Dialyse

Magdeburg, , Germany

Dialysezentrum Pforzheim

Pforzheim, , Germany

Hospital Infanta Leonor

Madrid, , Spain

Complejo Hospitalario de Ourense

Ourense, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Western Health and Social Care Trust

Londonderry, , United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

Countries

Denmark; Germany; Spain; United Kingdom

References

de Francisco AL, Leidig M, Covic AC, Ketteler M, Benedyk-Lorens E, Mircescu GM, Scholz C, Ponce P, Passlick-Deetjen J. Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability. Nephrol Dial Transplant. 2010 Nov;25(11):3707-17. doi: 10.1093/ndt/gfq292. Epub 2010 Jun 7.

Reference Type: BACKGROUND

PMID: 20530499 (View on PubMed)

Other Identifiers

RP-OSV-01-EU

Identifier Type: -

Identifier Source: org_study_id